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January 17, 2022
by Joanne S. Eglovitch

Recon: Pfizer to increase COVID-19 antiviral output with French deal; Unilever signals pursuit of GSK consumer arm

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA advises physicians to consider alternatives to Endologix AFX2 endovascular grafts (MedTech Dive)
  • Moderna CEO says data for Omicron-specific shot likely available in March (Reuters)
  • Martin Shkreli is ordered to pay $64 million and is banned from the pharma industry for life (STAT) (Washington Post)
  • A $3B+ peak sales win? Pfizer thinks so, as FDA offers a tardy green light to its JAK1 drug abrocitinib (Endpoints)
In Focus: International
  • Global vaccine-sharing programme reaches milestone of 1 billion doses (Reuters)
  • WHO recommends two new drugs to treat COVID-19 (WHO)
  • Return of the flu: EU faces threat of prolonged 'twindemic' (Reuters)
  • Unilever Pursues Glaxo and Pfizer Consumer Health Venture (NYTimes) (Reuters 1, 2) (Scrip)
  • Pfizer to boost COVID-19 pill production with French deal (Reuters)
  • Canada approves Pfizer's COVID-19 oral antiviral treatment for adults (Reuters)
  • Europe preps for the launch of its new clinical trials database, with a push to increase trial participation (Endpoints)
  • EU New Drug Approvals Hit Record High (Pink Sheet)
  • India's Gennova developing Omicron-specific COVID-19 vaccine (Reuters)
  • 2021 Saw India Enable Accelerated Regulatory Pathways – Can It Become The Norm? (Pink Sheet)
Coronavirus Pandemic
  • Biden Pledges A Billion COVID-19 Tests, Announces Plan Requiring Private Insurers To Pay For At-Home Diagnostics (MedTech Intelligence)
  • Biden administration to buy 500M more rapid COVID-19 tests to give free to Americans (MedTech Dive)
  • For Coronavirus Testing, the Nose May Not Always Be Best (NYT)
  • Analysis: CDC Grapples With Rapidly Evolving Virus and Imperfect Data (NYT)
  • French parliament approves vaccine pass (Reuters)
  • Israeli study shows 4th shot of COVID-19 vaccine less effective on Omicron (Reuters)
  • Analysis: China's 'zero-COVID' campaign under strain as Omicron surges (Reuters)
  • UK's Johnson plans to scrap COVID-19 self-isolation law - The Telegraph (Reuters)
  • Australia PM blames Omicron for testing woes as COVID-19 cases hit downward trend (Reuters)
  • Nepal starts giving COVID-19 vaccine booster shots (Reuters
Pharma & Biotech
  • Pfizer And Abbvie JAKs Finally Join Dupixent In US Dermatitus Space (Scrip)
  • After nabbing two AI-generated molecules, AstraZeneca returns to BenevolentAI with new collaboration (Endpoints)
  • First Academic Sponsor On EMA’s PRIME Pledges Cheaper CAR-Ts (Pink Sheet)
  • Vir expands partnership with Gates Foundation, adding $50M for HIV and malaria antibody research initiative (Endpoints)
  • Biopharma dealmakers reflect on last year’s shifts in the market, as they gear up for another ‘active’ year ahead (Endpoints)
  • ‘Challenges Ahead’ For Cell And Gene Therapy, Notes Catapult’s New Chairman McCubbin (Pink Sheet)
  • JPM22 - The gene editing revolution: Now it's time for human data to define a fast-changing field (Endpoints)
  • Scientists are making CAR-T cells more clever. Here’s what the next generation could look like (STAT)
  • Strong new evidence suggests a virus triggers multiple sclerosis (STAT)
  • Exclusive: Biogen leaders warn sales teams: Only 2,000 patients might access Aduhelm over the next several years (Endpoints)
Medtech Government, Regulatory & Legal
  • J&J, New Mexico Ink $44M Opioid Settlement (Law360)
  • 5 Questions After High Court Smacks Down Vax-Or-Test Rule (Law360)
  • Hospitals Confront the Fallout From Supreme Court Ruling on Vaccine Mandate (NYT)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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